# China NMPA Product Recall - Medical protective masks D918 and D912

Source: https://www.globalkeysolutions.net/records/china_product_recall/shandong-yixing-medical-equipment-co-ltd/50613961-eb12-4ed9-8d03-96eec2656029/
Source feed: China

> China NMPA product recall for Medical protective masks D918 and D912 by Shandong Yixing Medical Equipment Co., Ltd. published July 01, 2022. Recall level: Level 3 Recall. Shandong Sino Medical Device Co., Ltd. initiated a voluntary recall of its medical protective masks,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shandong Sino Medical Device Co., Ltd. voluntarily recalls medical devices
- Company Name: Shandong Yixing Medical Equipment Co., Ltd.
- Publication Date: 2022-07-01
- Product Name: Medical protective masks D918 and D912
- Recall Level: Level 3 Recall
- Recall Reason: Upon inspection of retained samples, it was found that materials supplied by some suppliers, after prolonged storage, could lead to defects in the corresponding products.
- Discovering Company: Shandong Sino Medical Equipment Co., Ltd.
- Manufacturing Company: Shandong Yixing Medical Equipment Co., Ltd.
- Summary: Shandong Sino Medical Device Co., Ltd. initiated a voluntary recall of its medical protective masks, models D918 and D912 (Registration Certificate No.: Lu Xie Zhu Zhun 20172140062), effective July 1, 2022. The company's decision stems from the discovery of material defects in components supplied by certain vendors, which became apparent after extended storage periods. This voluntary action, categorized as a Level III recall, aims to address the identified product issues and ensure public safety. The recall details, including specific models, specifications, and affected product batches, are further elaborated in an accompanying "Medical Device Recall Event Report Form." This recall is overseen within the regulatory framework of the National Medical Products Administration (NMPA), with the initial announcement published by the Shandong Provincial Drug Administration. Shandong Sino Medical Device Co., Ltd. is undertaking the necessary steps to manage and resolve the identified product non-conformance through this voluntary recall process.

Company: https://www.globalkeysolutions.net/companies/shandong-yixing-medical-equipment-co-ltd/d3ea3daa-2a11-4a60-8def-8e3e5424d696/